European Union - English - EMA (European Medicines Agency)

tesaro bio netherlands b.v. - rolapitant - vomiting; nausea; cancer - antiemetics and antinauseants, - prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.varuby is given as part of combination therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

tesaro uk ltd - rolapitant hydrochloride monohydrate - tablet - 90mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

tesaro uk ltd - niraparib tosylate monohydrate - capsule - 100mg

United States - English - NLM (National Library of Medicine)

tesaro, inc. - niraparib (unii: hmc2h89n35) (niraparib - unii:hmc2h89n35) - niraparib 100 mg - zejula® is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. zejula® is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either: - a deleterious or suspected deleterious brca mutation, or - genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy [see clinical studies (14.2)] . select patients for therapy based on an fda-approved companion diagnostic for zejula. none. risk summary based on its mechanism of action, zejula can cause fetal harm when administered to pregnant women [see clinical pharmacology (12.1)] . there are no data regarding the use

Israel - English - Ministry of Health

medison pharma ltd - niraparib as tosylate monohydrate - hard capsule - niraparib as tosylate monohydrate 100 mg - niraparib - zejula is indicated:• as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.• as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - niraparib tosilate monohydrate 159.4mg equivalent to niraparib 100mg;   - capsule - 100 mg - active: niraparib tosilate monohydrate 159.4mg equivalent to niraparib 100mg   excipient: black ink sw-9049 brilliant blue fcf erythrosine gelatin lactose monohydrate magnesium stearate tartrazine titanium dioxide white ink sb-007 - zejula is indicated for: the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Israel - English - Ministry of Health

taro international ltd, israel - pemetrexed - powder for concentrate for solution for infusion - pemetrexed 100 mg/vial - pemetrexed - 1.pemetrexed taro in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. 2.pemetrexed taro in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. 3.pemetrexed taro is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.4.pemetrexed taro is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Israel - English - Ministry of Health

taro international ltd, israel - pemetrexed - powder for concentrate for solution for infusion - pemetrexed 1000 mg/vial - pemetrexed - 1.pemetrexed taro in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. 2.pemetrexed taro in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. 3.pemetrexed taro is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.4.pemetrexed taro is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Israel - English - Ministry of Health

taro international ltd, israel - pemetrexed - powder for concentrate for solution for infusion - pemetrexed 500 mg/vial - pemetrexed - 1.pemetrexed taro in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. 2.pemetrexed taro in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. 3.pemetrexed taro is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.4.pemetrexed taro is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Israel - English - Ministry of Health

taro international ltd, israel - dasatinib - film coated tablets - dasatinib 100 mg - dasatinib - dasatinib taro is indicated for the treatment of adult patients with: * newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase. * chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib mesilate. * ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy.